The conclusion of the pharmaceutical package by the European Union is a significant moment in shaping the future of one of Europe’s most strategically important sectors, supporting the health and economic security of Europe and impacting patient care for decades.

While the package contains signals that the EU recognises the importance of the legislation as a key driver of competitiveness for the innovative pharmaceutical sector in Europe, it is not strong enough to move the needle on European competitiveness – a key objective of this Commission.

If Europe truly wants to be competitive it needs to increase investment in innovative medicines, strengthen rather than weaken IP and make the process of getting new medicines to patients faster and more connected.

The decision to maintain the status quo with eight years of regulatory data protection (RDP) is an improvement on the earlier European Commission proposals but is not enough to attract and retain global investment into European R&D. The situation is worse for rare diseases, with erosion of market exclusivity incentives (10 to 9 years), although this is balanced by other positive provisions for breakthrough therapies.

The extension of the Bolar exemption is also an unnecessary move that will frustrate IP enforcement and create legal uncertainty, further eroding competitiveness within the innovative sector.

These compromises are from a previous political era and will make no difference for a sector already losing ground. To compete in 2026 and beyond, Europe requires policies that can halt the negative trends of previous years while also countering the fallout of recent global pricing and trade policies, ensuring that we can continue to lead global innovation in medicines and vaccines.

In this sense, the updating of the EU’s regulatory framework provides an important shift, with encouraging steps towards reducing EMA timelines and the ability to compete with the FDA and other global medicines agencies. The introduction of a regulatory sandbox strengthens Europe’s toolbox for supporting breakthrough innovations. We support the long-awaited transition to electronic product information, bringing essential flexibility and aligning regulation with technological progress.

The introduction of a transferable exclusivity voucher (TEV) with a complementary voluntary subscription model to stimulate the research and development of new antibiotics and antimicrobials is also an important step towards tackling a major health crisis - with Europe at the forefront. However, this comes with caveats, as there are conditions applied. Evaluation and implementation will be critical.

Nathalie Moll, Director General, EFPIA: “Our region has lost a quarter of its global share of investment to other parts of the world in two decades, while our share of clinical trials has halved.

If this is the legislative framework that is expected to attract the medicines innovation of the next 20 years to Europe, the outcome of the trialogues is underwhelming. 

If Europe truly wants to be competitive it needs to increase investment in innovative medicines, strengthen rather than weaken IP and make the process of getting new medicines to patients faster and more connected.

We now look to the Biotech Act and remain hopeful of policies to reverse the current trends, as well as a renewed enthusiasm to value and prioritise healthcare innovation in Europe.”